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Sport-Related Flow Limitations in the Iliac Arteries: Validation of Innovative Diagnostic Techniques, posture change and postoperation differences

Sport-Related Flow Limitations in the Iliac Arteries: Validation of Innovative Diagnostic Techniques, posture change and postoperation differences

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27245
Enrollment
300
Registered
2020-04-24
Start date
2013-02-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sport-Related Flow-Limiations in the Iliac Artery

Interventions

The study is designed as a prospective observational study without any invasive measurements. After written and oral informed consent, t0 and t1 measurements will be performed. If the participant is w

Sponsors

ZonMw: 75020017
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female aged>18; 2. Endurance athlete for at least three years = 5 hours per week of training 3. Unilateral- or bilateral pain, cramp and/or powerlessness in the leg or legs during (sub)-maximal exercise which disappears within a few minutes after ceasing exercise; 4. Proved sport-related flow-limitations as a result of kinking and/or intravascular lesions, diagnosed with duplex-Doppler echography examination For control subjects the same in and exclusion criteria except those regarding to sport-related flow limitations

Exclusion criteria

Exclusion criteria: 1. No operative vascular reconstruction in the iliac region 2. No diagnosed heart failure according to the New-York Heart Association stage>1 3. Cardiovascular risk 4. Atherosclerosis 5. Lumbar herniated discs 6. Complaints do not seem to be restricted to one muscle group or tendon; For control subjects the same in and exclusion criteria except those regarding to sport-related flow limitations

Design outcomes

Primary

MeasureTime frame
Reproducibility: 1. Difference (paired T-test when normally distributed) 2. Agreement (intra-class correlation coefficients, (ratio) limits of agreement and coefficients of variation, Bland-Altman) Diagnosis: 1. Difference (paired T-test when normally distributed) 2. Model for detecting sport-related flow-limitation (GLM/GLMNET; ROC curve) Posture: 1. Difference (paired T-test when normally distributed) Surgery: 1. Difference (paired T-test when normally distributed)

Secondary

MeasureTime frame
Correlations to ABI and Peak Systolic Velocities

Contacts

Public ContactMartijn van Hooff

Máxima MC

m.vanhooff@mmc.nl0408888000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)